Shunt device



March 31, 1970 R. R. SCHULTE 3,503,402

SHUNT DEVICE Filed March 25, 1966 INVENTOR. RUDOLF R SCHULTE A TTORNEYS.

United States Patent 3,503,402 SHUNT DEVICE Rudolf R. Schulte,,3328 Calle Fresno, Santa Barbara, Calif. 93105 Filed Mar. 23, 1966, Ser. No. 536,685

Int. Cl. A61m 27/00 U.S. Cl. 128-350 2 Claims ABSTRACT OF THE DISCLOSURE This invention relates to a device for use in physiological shunt circuits. It includes in a shunt system. which has an inlet and an outlet, a first and a second chamber each with a resilient wall connected in series between the inlet and outlet, the second chamber including a check valve comprising a ported flexible diaphragm. The two chambers are made of homogeneous material and shaped to lie flat against bony structure. The homogeneity avoids complications which arise with the use of dissimilar materials in a flow stream containing electrolytes, and the flatness reduces cosmetic distortions of the person in whose body the device is implanted.

This invention relates to auxiliary devices for use in physiological shunt circuits.

The drainage of unwanted fluid from one part of the body to another by providing a shunt passage for the fluid is well known. An example is shown in U.S. Patent No. 3,020,913 to Heyer. In the usage of shunts (which shunts may or may not include check valve means) auxiliary means are often provided for supplemental functions. An example of such a situation is shown in U.S. Patent No. 3,111,125 to Schulte. In this patent, a chamber having a resilient wall (sometimes herein called a lozenge) is combined with a shunt, which lozenge, while permitting unimpeded flow therethrough (and through the shunt), is also actuable as a pump to clear the downstream end of the shunt, and to test the openness of the upstream end.

It is an object of this invention to provide new and novel auxiliary means which provides not only the func* tions of the aforementioned Patent No. 3,111,125, but also enables medication, dyes, or test solutions to be directed selectively to body regions adjacent to either end of the shunt, and also to enable pressure surges to be directed to either end. The advantages of such a system, in addition to those possessed by the system of the aforementioned Schulte patent, are the capacity to clear the inlet end by a pressure pulse, and the capacity selectively to direct medication, dyes, test solutions, and the like bidirectionally in a shunt system which heretofore has been adapted only for unidirectional flow.

An additional feature is a construction providing the above functions which is optimally shaped for its purposes and can be made of homogeneous materials.

This invention is carried out in combination with a shunt tube that has an inlet end and an outlet end. A first lozenge (chamber) has an internal cavity that is bounded at least in part by a puncturable, self-sealing flexible resilient wall, and there is an inlet and an outlet to said cavity. This inlet is connected to the inlet end of the shunt tube.

A second lozenge (chamber) has an internal cavity and an inlet and an outlet to this last-named cavity. Its inlet and the outlet of the first lozenge are interconnected. A seat is provided in the cavity of the second lozenge that surrounds this inlet. A flexible diaphragm overlays the seat and is adapted to move toward and away from the same so as to close it or to leave it open. A puncturable, self-sealing flexible lozenge (chamber) wall is disposed 3,503,402 Patented Mar. 31, 1970 on the opposite side of the diaphragm from the seat, the diaphragm having a port therethrough outside the region adapted to contact the seat, whereby all parts of the cavity in the second lozenge outside of the seat are in constant fluid communication with the outlet of the sec- 0nd lozenge. The outlet of the second lozenge is connected to the outlet end of the shunt tube. According to a preferred but optional feature of the invention, the first lozenge is adapted to fit in a body opening with its inlet directly therein, and with its outlet directed flat against the body, and the inlet and the outlet of the second lozenge are direct flat against the body, the seat rising into the second lozenge from the inlet.

According to a feature of this invention both lozenges are made of a homogeneous material.

The above and other features of this invention will be fully understood from the following detailed description of the accompanying drawings, in which:

FIG. 1 is an axial cross-section of the presently preferred embodiment of the invention in its open condition;

FIG. 2 is an illustration of FIG. 1 in another condition; and

FIG. 3 is a perspective view of the invention showing another condition of its use.

As best shown in the invention, the combination is adapted to fit next to a portion of the human body 10, the portion specifically shown therein being the skull at the occipital bone 11. The brain 12 underlies this bone and a hole 13 is formed in the bone.

A shunt tube 14 has an inlet end 15 and an outlet end 16. As best shown in FIG. 3, the inlet end lies within the brain to drain a portion thereof, and the outlet end is directed toward the heart. The outlet end is or may be of the type shown in aforesaid Patent No. 3,020,913. The inlet end may be an open-ended catheter tube.

A first lozenge 20 is generally circular in plan and includes an internal cavity 21, this cavity being bounded at least in part by a puncturable, self-sealing flexible, resilient, wall 22. An inlet 23 and an outlet 24 enter into the cavity through the wall of the first lozenge. Inlet 23 connects to the inlet end of the shunt tube and outlet 24 connects to a flexible connector 25. While the inlet end, outlet end and flexible connector are shown continuous with the lozenges, it will be understood that in practice, connectors are likelier to be used than continuous formation or bonding together of the structures, although the latter may be used. Such connectors may be cylinders to which tube ends may be aflixed, such as by bonding, friction, or suturing.

A second lozenge 30 has an internal cavity 31 and an inlet 32 and an outlet 33. A seat 34 surrounds the inlet and rises as a crown above it. A flexible lozenge wall 35, which is puncturable and self-sealing, overlays the seat and at least partially bounds the cavity. Between the seat and this wall there is a flexible diaphragm 36 that extends across the cavity and makes a continuous seal with the wall thereof. The diaphragm has at least one port 37 therethrough which lies in the region outside the seat and thereby maintains steady fluid communication through the entire cavity with the outlet. The outlet of the second lozenge connects with the outlet end of the shunt.

It will be noted that the inlet of the first lozenge is directed at substantially right angles to the outlet end, so the outlet is adapted to lie flat along the body while the inlet end is adapted to project into the body. Both the inlet and the outlet of the second lozenge are adapted to lie flat against the body. This is the preferable embodiment where the first lozenge may fit nicely into the hole which must be formed in the skull to insert the catheter, While the second lozenge lies fiat so as to provide as little deformation of the skin as necessary. It will, however, be recognized that the inlet and outlet of the first lozenge could be directed substantially parallel so that they may lay flat if desired. This latter arrangement will be suitable when the catheter may bend around corners without being pinched. The illustrated arrangement prevents pinching of the catheter by making separate provisions for the necessary bend.

The use of the device should be evident from the foregoing. In the condition of FIG. 1 there is a straightthrough drainage, which is the normal condition of operation. FIG. 2 illustrates a pumping function which may also be accomplished with the device shown in Schulte Patent No. 3,111,125. When a pumping pulse is to be provided, the flexible wall of the second lozenge is pressed down, which moves the flexible diaphragm to close the seat, and then fluid which is contained within the cavity of the second lozenge is expelled by further compression of the lozenge out the outlet end. When the second lozenge is released, its refilling from the inlet end will be noted by a return to the configuration of FIG. 1. If the flexible wall does not return (it is molded to the form of FIG. 1, and tends to return to that shape unless restrained therefrom), then it may be concluded that the inlet end of the shunt is occluded. This reaction occurs when there is a check valve at the outlet end of the shunt tube. Howeven if there is no check valve at the outlet end, the pumping pulse or pressure pulse can still be generated as shown.

Now to obtain a pressure pulse at the inlet end, the second lozenge may be compressed to the position shown in FIG. 2 (which, incidentally, provides a pressure pulse at the second end) and then the first lozenge is compressed. This will create a pressure pulse at the inlet end. Should it not be desired to cause a pressure pulse at the outlet end, then the finger may be applied to the outlet end as in FIG. 3 to squeeze the tube closed, or it may be applied to the flexible connector 25 for the same purpose and then the first lozenge compressed.

It will now be seen that pressure pulses may selectively be applied to either end of the shunt tube and also the standard free-flow, or pumping pulse-flow, necessary in many shunts may be provided as well.

Some of the advantages of these pulses are illustrated in FIG. 3 where a hypodermic needle 38 is shown injecting material which might be a test solution or a medication of some kind into the first lozenge. Now, it the needle is removed and the first lozenge compressed, the medication will be injected into the brain through the inlet end of the shunt, because the outlet end is held shut by the finger. Should it have been desired to inject solution in the opposite direction, then the solution would have been injected into the second lozenge and the second lozenge would simply have been pumped as in FIG. 2 so as to move the fluid out the outlet end. It will thereby be seen that this device enables surprisingly new and useful procedures to be undertaken without disturbance to the patient.

All components of the invention may conveniently be made of medical grade silicone rubber which is readily molded to the configurations shown. A significant advantage of making the two lozenges entirely of a given material (homogeneous construction) is that electrolytic and other effects are avo ded h h n es t w en me l check valves, for example, are used in a system. The structure illustrated is adapted to take advantage of homogeneity of structural material. Should connectors be used, the may be of the common nylon or delron materials, which need to be somewhat stifler than the move flexible material of the remainder of the construction.

This invention is not to be limited by the embodiment shown in the drawings and described in the description, which are given by way of illustration and not of limitation, but only in accordance with the scope of the appended claims.

I claim:

1. In combination with a shunt tube having an inlet end and an outlet end: a first chamber having an internal cavity bounded at least in part by a puncturable, self-sealing, flexible resilient wall, and an inlet and an outlet to said cavity, said inlet being connected to the inlet end of the shunt tube; a second chamber having an internal cavity and an inlet and an outlet to said last-named cavity, its inlet and the outlet of the first chamber being interconnected, a seat in the cavity of the second chamber surrounding its inlet, a flexible diaphragm overlaying said seat and adapted to move toward and away from the same to close or leave it open, a puncturable, self-sealing, flexible resilient chamber wall on the opposite side of the diaphragm from the seat, the diaphragm having a port therethrough outside the region adapted to contact the seat, whereby all parts of the cavity in the second chamber outside of the seat are in constant fluid communication with the outlet of the second chamber, the outlet of the second chamber being connected to the outlet end of the shunt tube, whereby a pressure pulse may be produced at the outlet end by compressing the second chamber so as to cover the seat with the diaphragm, and to expel fluid in the second chamber from the outlet end of the shunt, and whereby a pressure pulse can be produced at the inlet end by compressing the first chamber while the system downstream is closed, and to expel fluid in the first chamber from the said outlet end of the shunt, both chambers, the seat, and the diaphragm being made of the same homogeneous material, the first chamber having its inlet adapted to enter a body normal thereto and its outlet normal to the inlet so as to lie fiat against bony structure, both the inlet and outlet of the second chamber being adapted to lie parallel to the said bony structure, with the seat axis lying normal thereto and the diaphragm plane lying normal to said axis.

2. A combination according to claim 1 in which the said material is silicone rubber.

References Cited UNITED STATES PATENTS 11/1963 Schulte 128-350 OTHER REFERENCES DALTON L. TRULUCK, Primary Examiner (i/E, UNI'I'I'JU S'I'A'IES PA'I'ICN'I OFFICE CERTIFICATE OF CORRECTION FEES?! 3%:

3.11. Schulte InventoflnL 7 It is certified that error appears in the aboveand that said Letters Patent are hereby corrected as identified patent shown below:

Column 2, line 50, after "lozenge" and beforo "30" insert N chamber-q Column 3, line 23, "How" should be --However-- Column 4, line 39, "outlet" should be "inlet-- SIGNED AND SEALED mum N 5; Anal:

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